Renal studies have examined the safety and efficacy ONGLYZA in patients with moderate and severe renal insufficiency or end-stage renal disease (ESRD). 12-week data showed that ONGLYZA 2,5 mg once daily significantly improved glycoslated hemoglobin (HbA1c) from baseline compared with placebo when added to patients of the current treatment of diabetes. In patients with chronic renal failure, ONGLYZA and placebo showed numerically comparable reduction of HbA1c. This fact is inconclusive, since the court was not properly working, to show effectiveness in specific subgroups of renal failure. The frequency of side effects was similar ONGLYZA and placebo.
Data from individual 52-week study comparing ONGLYZA to titrated glipizide in patients with inadequate glycemic control on metformin plus diet and exercise showed that ONGLYZA metformin provided similar HbA1c reduction from baseline. This conclusion may be limited to patients with baseline HbA1c comparable to those in court. ONGLYZA metformin also resulted in significantly fewer confirmed hypoglycemia and weight loss compared with weight gain, compared with titrated glipizide plus metformin.
ONGLYZA indicated as an adjunct to diet and exercise to improve blood sugar (glucose) control in adult patients with type 2 diabetes in various clinical situations. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (dangerously high levels of ketones in the blood or urine).
“Many people with type 2 diabetes also experience impairment of the kidney, which may limit treatment options. With this update, ONGLYZA now includes efficacy and safety data in its label support its use in this important population,” said Elliott Sigal, MD, Ph. D., executive vice president, chief scientific officer and president of Research and Development, Bristol-Myers Squibb. “A Comparative Study ONGLYZA to titrated glipizide is another proof for ONGLYZA as an adjunct to metformin therapy.”
If used with insulin secretion such as sulphonylureas, low-dose insulin secretion may be necessary to reduce the risk of hypoglycemia. There have been no clinical studies creating compelling evidence of macrovascular risk reduction with ONGLYZA or any other anti-diabetic drugs.
Efficacy and safety ONGLYZA type 2 diabetic patients with renal insufficiency
A total of 170 adult patients who participated in the 12-week, randomized, double-blind, placebo-controlled trial. The study was conducted to assess the efficacy and safety ONGLYZA 2,5 mg once daily compared with placebo in patients with type 2 diabetes and moderate.
After 12 weeks of treatment, ONGLYZA 2,5 mg once daily provided significant improvements in HbA1c compared to placebo. ONGLYZA 2,5 mg group (mean baseline HbA1c 8,4%) showed a higher adjusted mean change in HbA1c from baseline -0.9% compared with -0.4% in the placebo group (mean baseline HbA1c 8,1%, p50 mL / min). Assessment of renal function is recommended prior to ONGLYZA and periodically thereafter.
Efficacy and safety of metformin ONGLYZA against titrated glipizide plus metformin in type 2 diabetic patients
In the 52-week, randomized, double-blind, active-controlled study of 858 adult patients with type 2 diabetes and inadequate glycemic control, ONGLYZA>
More than two-thirds of the patients in the glipizide metformin group was split into two or three doses of glipizide titration, with an average final daily dose of 15 mg.
Twelve times less ONGLYZA 5 mg plus metformin patients vs. glipizide plus metformin patients experienced hypoglycemic events: 3.0% (19 events in 13 patients) versus 36.3% (750 events in 156 patients), respectively. Confirmed symptomatic hypoglycemia (accompanying blood glucose from a finger ≤ 50 mg / dL) were reported in any of ONGLYZA patients and in 35 of glipizide patients (8.1%, p
